External Manufacturing Operations, Senior

The External Manufacturing Operations, Senior Specialist is accountable for meeting customer demand at the External Partner site. They support by achieving excellence in Compliance, Supply, Continuous Improvement & Cost through their leadership and coaching of the responsible cross functional teams and their work in partnership with those external party's while leveraging our Production System principles (MPS) and the end-to-end supply chain.

The Specialist will be working onsite at an external partner in Val De Reuil, Normandy, France.

**Primary Activities**:

- Bring Virtual Plant Management support within external manufacturing operations working with the Associate Director, EXM Operations and part of the Focus Factory Team.
- Support our Manufacturing Division relationship with the external partner in Val De Reuil, France.
- Ensure compliance in Quality Risk management, Deviation Management, Product Release, Change Control, and meeting demand.
- Handle dispute resolution with appropriate escalation and oversee production planning and materials management (MRP entries, logistics).
- Address technology issues and provide oversight of shop floor production, determining when an External Manufacturing functional representative should be deployed to the external party's facility.
- Drive risk assessment across the value chain, working closely with the Focus Factory team and partner to manage and mitigate risks for uninterrupted supply chain and 100% compliance in quality and environment, health, and safety.
- Build a strong relationship with the site's leadership team, assess and diagnose the current condition & risks at a partner site, and formulate improvement plans in partnership with external partners and cross-functional teams.
- Partner with ExM Procurement, Quality, and Technology on commercial aspects of the relationship, including identification, selection, negotiation, and termination if required.
- Participate and represent External Manufacturing on cross-functional teams for due diligence ahead of siting approval and post-siting approval to support SOS/NPI changes at an external party.
- Understand the external partner's capacity, firm capacity, future capacity plans, and time horizon/lead times required.
- Maintain the integrity of the MSA (Master Supply Agreement), ensuring alignment with supply and quality agreements, and manage contract terms.
- Take responsibility for inventory control and ensure adequate documentation of material disposition, including witnessing or certifying the destruction of goods as needed.
- Support internal and partner's Production System improvements.
- Support the external partner's periodic Business and Operations Review Meetings, develop annual priorities, and set clear goals and targets.
- Support presentations and strategic initiatives for network actions to enable World Class Supply.
- Participate in the maintenance of an External Manufacturing Organization information containing Global ExM policies, procedures, templates, etc.

**Qualification**:

- Bachelor's degree preferably in Engineering, Science.
- Minimum 3 years’ experience in commercial /business and manufacturing preferred (operations, quality, technology, planning).
- Experience within the life science industry highly preferred.
- Full proficiency in French and English is a requirement for this position.
- Depth of Manufacturing Knowledge - Has proven skills and expertise at management level in modality (API, Drug Product, Sterile).

**Skills**:

- Work Environment - Adaptability to work in remote setting with remote teams.
- Compliance - Has experience and ability to achieve compliance goals, through a risk-based approach has a deep understanding of GMP and EHS compliance and quality compliance risk. Direct Health Authority Audit experience desirable.
- World Class Supplier Mindset - Has experience with Lean Six Sigma skills to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time.
- Strategic Thinking - Can Visualize the way forward, identifying opportunities that add value to the work and proactively mitigate risk across the value chain.
- Working Across Boundaries - Must possess excellent interpersonal, communication, collaboration, negotiation skills to work outside boundaries as a norm.
- Business Outcomes /Drive Results - Ability to use deep knowledge and expertise in production operations to drive results and business outcomes.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Hybrid

**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R283242